We are a Healthcare and Regulatory Affairs Consultancy with over 30 years experience.

Welcome to Martin Biggs Associates

Martin Biggs Associates is a healthcare / regulatory affairs consultancy with over 30 years experience. We can provide advice and assistance with European, Australian, South African, Chinese and US – FDA authorization of drugs, devices, drug/device combinations, IUDs, and cosmetics.

REGISTRATION REGULATORY AFFAIRS – REIMBURSEMENT DEVELOPMENT

  • Drug / Medicinal Product registration in Europe and other territories
  • CE marking / Medical Devices
  • FDA Drug and Device registration
  • Reimbursement of Drugs / Devices / Borderline Products / Food Supplements
  • In vitro Diagnostics registration
  • Stategic business planning and acquisitions
  • Trademark searches and registration
  • Patent and distributor searches
  • Patenting – intellectual property management and marketing advice
  • EU Cosmetics Directive
  • Expert reports
  • Advice as to choice of Notified Body and Competent Authority
  • Advice on the most cost effective route to CE marking and the choice of Annex
  • Selected List Scheme (SLS) and the Pharmaceutical Price Regulation Scheme (PPRS)
  • Due diligence studies / risk analysis studies
  • Authorized Representative services for Drugs, Devices, and Cosmetics
  • Expert witness service
  • Strategic marketing / pricing

Consult us on a strictly confidential basis

Others do and have found our services profitable

We are active participants in the Drug Tariff Forum, which meets under the auspices of the ABPI, and a member of the Expert Witness Institute.

Are you having difficulty in obtaining listing of your product in the Drug Tariff?

Do you need assistance with defending your brands against generic competition?

Do you need advice on NICE cost-effectiveness reviews?